MAUDE Adverse Event Report: CORDIS US CORP. SMART FLEX; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number SF08150MB

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2023

Event Type  malfunction  

Manufacturer Narrative

The product history record review is anticipated; however, it has not yet been finalized.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, when deploying a smart flex 8mm x150 mm biliary stent, the shaft of the delivery system "sheared off"; the covering on the stent shaft was bunched up.There was no reported patient injury.The access site was femoral.The target site was the superficial femoral artery (sfa).Vessel characteristics at target site included calcification, no tortuosity and ninety-five per cent stenosis.The device was not being used for treatment of a chronic total occlusion (cto).The device was stored as per labeling and opened in sterile field.There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty removing the product from the packaging nor difficulty noted during prep.The guidewire was prepped before loading on the device.There was no resistance when advancing through the sheath and no unusual force used during the procedure.The procedure was successfully completed.The device is expected to be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 308368 presented no issues during the manufacturing process that could be related to the event reported.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

When deploying a smart flex 8mm x150 mm biliary stent, the shaft of the delivery system "sheared off"; the covering on the stent shaft was bunched up.The access site was femoral.The target site was the superficial femoral artery (sfa).Vessel characteristics at target site included calcification, no tortuosity and ninety-five per cent stenosis.The device was not being used for treatment of a chronic total occlusion (cto).The device was stored as per labeling and opened in sterile field.There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty removing the product from the packaging nor difficulty noted during prep.The guidewire was prepped before loading on the device.There was no resistance when advancing through the sheath and no unusual force used during the procedure.The procedure was successfully completed.There was no reported patient injury.The device was returned for analysis.A non-sterile unit of product ¿smart flex 8x150 bil, 120cm¿ was received coiled inside of a clear plastic bag.The device was unpacked and was laid flat on a tray to proceed with the product evaluation.The unit was thoroughly inspected observing that the stent is fully deployed and was no returned for analysis.The hemostasis valve is tight closed, the body/shaft presents a kinked condition located approximately on 117 cm from the distal tip.An outer sheath separation is observed located approximately at 128.5 cm from the distal tip.No coating delamination was observed.No other damages or anomalies were observed on the returned device.The separated area was analyzed using a vision system to magnify the damage.Results showed that the edges on the separated area presented evidence of elongations.The elongations found on the plastic material and the plastic deformation are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.A product history record (phr) review of lot 308368 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported by the customer as ¿coating- delaminated" was not confirmed, the coating does not present any delaminated condition.However, the returned unit presents a separated condition and a kinked condition.The exact cause of the observed separated condition and the kinked condition could not be determined during the analysis.It is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.Procedural factors and handling process may have contributed to the observed damages.According to the instructions for use (ifu) ¿examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used¿.The product evaluation does not suggest that the reported event experienced by the customer is related to the manufacturing process; therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SMART FLEX
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16906792
• MDR Text Key: 314950699
• Report Number: 3005089785-2023-00123
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 20705032065624
• UDI-Public: (01)20705032065624(17)240816(10)308368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SF08150MB
• Device Lot Number: 308368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.